A Phase 1 Study of MM-141 in Patients With Advanced Solid Tumors

This study is currently recruiting participants.
Verified March 2014 by Merrimack Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01733004
First received: November 20, 2012
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design, evaluating MM-141 at varying dose levels and frequencies.


Condition Intervention Phase
Advanced Solid Tumors
Drug: MM-141
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study of MM-141 in Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Merrimack Pharmaceuticals:

Primary Outcome Measures:
  • Severity and number of adverse events related to escalating doses of MM-141 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Determine the Phase II dose based either on the maximum tolerated dose (MTD) or recommended dose in patients with advanced solid malignancies.


Estimated Enrollment: 45
Study Start Date: November 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
MM-141 monotherapy
Drug: MM-141
Experimental: Arm B
MM-141 and Everolimus
Drug: MM-141
Experimental: Arm C
MM-141 and Abraxane and Gemcitabine
Drug: MM-141

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced malignant solid tumors for which no curative therapy exists that has recurred or pgrogressed following standard therapy
  • Eighteen years of age or above
  • Able to understand and sign an informed consent (or have a legal representative who is able to do so)
  • Measurable disease according to RECIST v1.1
  • ECOG Performance Score of 0 or 1
  • Adequate bone marrow, hepatic, renal and cardiac function
  • Willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of MM-141

Exclusion Criteria:

  • Active infection or fever > 38.5°C during screening visits or on the first scheduled day of dosing
  • Symptomatic CNS disease
  • Received other recent antitumor therapy
  • Pregnant or breast feeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733004

Contacts
Contact: Akos Czibere, MD, PhD 617-441-1000

Locations
United States, Georgia
Georgia Cancer Specialists Recruiting
Marietta, Georgia, United States
Contact: Christopher Moore, RHIT, CTR    770-496-9427    christopher.moore@gacancer.com   
Principal Investigator: Mansoor Saleh, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States
Contact: Steven Isakoff, MD, PhD    617-726-2000      
Principal Investigator: Steven Isakoff, MD, PhD         
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States
Contact: Karen Forman, BAA, CCRP    313-576-8096    formank@karmanos.org   
Principal Investigator: Patricia LoRusso, DO         
France
Institut Goustave Roussy Recruiting
Villejuif, France
Contact: Monica Arnedos, MD    0033 1 42 11 40 68    monica.arnedos@igr.fr   
Principal Investigator: Jean-Charles Soria, Pr         
Sponsors and Collaborators
Merrimack Pharmaceuticals
  More Information

No publications provided

Responsible Party: Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01733004     History of Changes
Other Study ID Numbers: MM-141-01-01-01
Study First Received: November 20, 2012
Last Updated: March 3, 2014
Health Authority: United States: Food and Drug Administration
France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Merrimack Pharmaceuticals:
Cancer
Solid tumors
Oncology
Phase I
ErbB3
IGF-1R
Everolimus
Gemcitabine
Abraxane

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 16, 2014